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I’m excited about ticking off the boxes that get us to IND filing - however I have no idea how many more of these studies need to be completed- and PMCB is not giving out that information. Which makes predicting an IND impossible for shareholders - I’m still optimistic about a Q4 filing though. Holding every share till the end.
Once they have cells in syringes really shouldn’t be more than a month to release the batch
Length of time depends on how many people are working on all this...
They would have wanted to run the engineering batch as if it were going to be released for use so they would need to wait for the released cells. They could have written the work instructions then tested them out in the eng. run. I think they took this long because they don’t have employees to do the work - they rely on others to get things done. Jmo
Nice quote 1234 - explains it all perfectly. We perform an engineering run to kick the tires on the process before performing the process validation runs - usually 5 scheduled and need three sequential runs without issues or minimal comments to the batch to file with the agencies - that’s been my experience but all companies have their own approach. Also any material produced in engineering runs was designated as R&D - never went into people. I think we’re on the right track just slower than we want it to be - but if PMCB team gets it right this tech is disruptive and very valuable.
I’m PMCB long for 4+ years
I’m not a fan of the silence either... waaay back in the beginning of my career I did rodent studies - we had 2week, 3 month , 6 month and 2 year studies. Typical rodents start dying of old age after 2 years. Short studies were dose determination- lethal dose levels, mid range were safety studies and 2 years studies were chronic exposure impact determination. So these studies could take a couple years but they probably would need to use larger species as well to satisfy regulators. Just thoughts.
I agree with there being interested parties in the wings waiting for milestones to be hit - Austrianova can drop hints as a privately held company that PMCB can’t as a publicly held company. Time will prove or disprove this notion. I will hold every share until that happens. GLTA
Agree! When not if. And also agree it will happen without notice - we’ll just wake up one morning and it will all be done. Thanks for all your thoughts everyday- I don’t post a lot but follow the Longs here.
Eurofins doesn’t do business with scams - they have standing contracts with big pharma (they did with two big companies I have worked for) and their reputation is everything to them. If they even had an inkling that PMCB was a scam they wouldn’t have produced our cell bank. They would have told us they couldn’t “fit us into their schedule.”
PMCB is no scam - if you’re just looking to fleece investors you don’t hire Eurofins to create your cell bank - you go find another cheap contractor to keep your game going. The IND will be filed it’s just a matter of when. I hope reports of Dr Crabtree’s Q3 happen. Good luck to all and yes that means the patients too.
I still believe we will get the IND filed, hopefully sooner than later. I seriously believe this tech will be a game changer for many diseases. While I am disappointed by the incomplete information we have gotten from Mr Waggoner, I do put it down to inexperience in biopharm and I continue to hold every share. Best of luck to all!
Great DD - Merck has been known to collaborate with Eli Lilly
That’s awesome-thanks for sharing
What I meant is a Merck or any big pharma partnership would bring efficient planning to the table and the research testing would have been performed starting in April when the cells actually arrived- if they did start In April, then telling us they were completing this testing at the time they announced cells were certified would have helped us understand they weren’t able to start production yet. true a buyout at this point would not make us as valuable but a partnership would give us skills, resources and real shareholder value. I don’t want to be bought yet but I do want us to get an experienced partner.
Merck KGaA- it’s the same logo all over the materials in our lab....
Best thing that could happen for shareholders is a big pharma partner because they would take the reigns and things will be measured against hard metrics and timelines with penalties for those who miss targets - the big guys don’t mess around. I’ve seen startups bought by big pharma and they turn things around fast - often removing anyone who is not getting things done- in truth it’s a bit ruthless but good for shareholders.
We were told that “we are there” for IND filing- which meant to me we just needed to produce and release clinical material- now we’re hearing about all this additional testing which frankly means we really aren’t “there”. Rather disappointing to keep hearing this stuff dribbling out.
Sounds like more new info we didn’t have - thanks for sharing. If we get a partner like Merck we’re going to see things get whole lot more organized and a hell of a lot faster than what has been trickling out here for too long....
Respectfully disagree
I worked for a company without phase 3 clinical trial that treated 4000 people a year under a humanitarian exemption- if this trial suddenly shows a significant number of tumors become operable you will see fast track especially with the new right to try act.
If they started clinical material in June I think August- but if not September-or even October....
If Austrianova didn’t thaw and start producing the clinical material the week after receiving the Eurofin certs then shame on them and poor planning imo.
It’s not the same thing although a few of the tests like sterility are which takes 14 days. Every batch a biotech makes undergoes release testing- which usually includes sterility and product specific tests that prove you made what you planned to . My experience is it takes about a month post production to do that then quality reviews all the paperwork and releases product- depending on the quality work load give them a couple weeks to do that. All the cell bank and IND testing is far more rigorous than release testing- you would only repeat the rigorous testing if you made a change to your cell bank or production process. Hope that helps.
Clinical production and “main” production are two different things. Main or what most call production runs are for product for the market- if they go into trials they need to be making product for post trial market- the agencies want to know you won’t have an immediate product shortage if you get approval- the near future production is where partnership or buyer comes in to pay for it- all jmo.
Yes DD team - no company in this business partners or buys anything without sending a team to see first hand what they’re putting money into. Usually consists of money people, quality people and scientists or production specialists. Austrianova is where the product is made so makes sense they went there - PMCB has probably already been visited by the money people and executives only - because they don’t manufacture the product.
I think they mean production runs are near future- it is my opinion that clinical material has been encapsulated already and is currently undergoing release testing to file IND. It is still my opinion that visitors to Singapore on July 3rd was a due diligence site visit and austrianova post yesterday only makes me think so more. Remember austrianova is a private company they can put out whatever they want unlike their partner PMCB who is publicly traded. I think we get some more news by end of July.
Maybe- but my personal experience in biotech is companies don’t like employees wearing other companies swag and partnerships or buyouts are always preceded by site visits for due diligence. This is all jmo. I could be wrong.
I think longs are holding and waiting for the news that can happen any day now - I know I am. Btw - the latest post from austrianova- in the picture the guy with his back to the camera is wearing a lanyard with the Merck logo on it - clue???
Imo yes
If they’re going to they should be announcing clinical material production is complete and release testing is nearing completion this week....
Nice proof of concept though and we know we don’t illicit the immune response to the implant! PC is the breakthrough then many will want that box. Great research Brian.
Nice! Thanks Brian.
Looks like PMCB is setting the stage for our partner or buyer.....
No one knows that for sure....
Given our internal connections with Celgene would could be one of their 4 multibillion opportunities- time will tell... always jmo.
You are 100% spot on 1234 (imo). The real value is in the platform and we have first right of refusal for a reason- and the cherry on top is all the pc lives that will be saved proving it.
I don’t have a lot of experience in IND filing but have an understanding of FDA requirements from years of working on the production side - when we changed to serum free media we had to requalify our process which included 5 full scale production runs a lot of testing and re file for approval with FDA EMA etc and had to get that approval before marketing the product- you basically can’t change anything without agency review and approval. hope that helps?
Going serum free is a requirement to market product in some countries because of bovine encephalitis risk associated with the component. I know one company I worked for went that route because We couldn’t sell in Japan if we didn’t. Definitely lowers risk using a medium without bovine serum. Good business decision.
Stability studies are needed for cell banks and for final product shelf life. My experience is the studies continue until you reach a point of cell bank viability decline and for product - a quality decline in a specific attribute(s) - sounds like they have generated enough data for IND filing. It’s more great news - as always jmo.
I couldn’t be happier to be a part of the treatment that saves lives through resectable tumors! If we see enough patients become operable the FDA will be within their rights to fast track the treatment and open it up for compassionate use. Let’s face it right now pc is a death sentence.